FDA Adverse Event
Malfunction
Summary report: N
DELTRAN IV PLUS
MDR report key: 1597711
·
Received January 26, 2010
Report
- Report Number
- 1597711
- Event Type
- Malfunction
- Date Received
- January 26, 2010
- Date of Event
- January 20, 2010
- Report Date
- January 26, 2010
- Manufacturer
- UTAH MEDICAL PRODUCTS, INC.
- Product Code
- DRS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TN, US
Narratives
Description of Event or Problem · 1
AS THE RESPIRATORY THERAPIST WAS ATTEMPTING TO DRAW BACK BLOOD, BLOOD WAS NOTED TO BE COMING FROM A HOLE IN THE TUBING. APPROXIMATE BLOOD LOSS NOTED TO BE APPROXIMATELY 1-2 ML. THE TUBING WAS IMMEDIATELY DETACHED FROM THE PATIENT. UPON INSPECTION, THE TUBING APPEARED TO HAVE A SPLIT NEXT TO WHERE IT WAS JOINED WITH THE HARD PLASTIC. THE EXACT LOT # IS UNKNOWN AS THE PACKAGING WAS NOT KEPT, HOWEVER THE FACILITY DOES HAVE LOT 1091508, 1092502 AND 1092386 CURRENTLY IN STOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTRAN IV PLUS | ARTERIAL BLOOD COLLECTION KIT | DRS | UTAH MEDICAL PRODUCTS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 DAY | NO OTHER THERAPIES |